NCT02554162

Brief Summary

This study examines if there are differences in satiety responses between structurally different wholegrain rye products.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 18, 2015

Completed
13 days until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

November 28, 2016

Status Verified

December 1, 2015

Enrollment Period

2 months

First QC Date

September 17, 2015

Last Update Submit

November 24, 2016

Conditions

Subjective Appetite and Satiety

Keywords

Satiety, appetite, wholegrain rye

Outcome Measures

Primary Outcomes (1)

  • Postprandial satiety, assessed using 10 cm visual analogue scale (0=not at all, 10=Extremely)

    In every 30 min until 210 min after consumption

Study Arms (5)

Extruded wholegrain rye flakes

ACTIVE COMPARATOR

Rye products with varying structures

Other: Rye products with varying structures

Extruded wholegrain rye puffs

ACTIVE COMPARATOR

Rye products with varying structures

Other: Rye products with varying structures

Fresh wholegrain rye bread

ACTIVE COMPARATOR

Rye products with varying structures

Other: Rye products with varying structures

Wholegrain rye beverage

ACTIVE COMPARATOR

Rye products with varying structures

Other: Rye products with varying structures

Fresh wheat bread

ACTIVE COMPARATOR

Rye products with varying structures

Other: Rye products with varying structures

Interventions

Rye products with varying structuresOTHER

The satiating effect of rye products with various structures will be studied

Extruded wholegrain rye flakesExtruded wholegrain rye puffsFresh wheat breadFresh wholegrain rye breadWholegrain rye beverage

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI 18.5-25 kg/m2
  • Habit of eating breakfast

You may not qualify if:

  • Significant changes in body weight (+ or - 4 kg) during the previous year
  • Smoking
  • Pregnant or lactating
  • Missing teeth (except 3rd molars)
  • Acute temporomandibular disorders (TMD)
  • Dietary restrictions possibly affecting the study (celiac disease, allergies or aversions to cereal foods/high carbohydrate foods)
  • Abnormal eating behaviour (according to EDDS (Eating Disorder Diagnostic Scale))

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aalto University

Espoo, Finland

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2015

First Posted

September 18, 2015

Study Start

October 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

November 28, 2016

Record last verified: 2015-12

Locations

FI(1)